This application claims priority to Chinese Patent Application No. 01103777.6 filed Feb. 12, 2001, entitled xe2x80x9cCOMPOSITION AND METHOD FOR EFFECTING WEIGHT REDUCTIONxe2x80x9d and the disclosure is hereby incorporated by reference.
The present invention generally relates to dietary supplements and foods for reducing weight gain, effecting weight loss and causing favorable changes in body composition. More specifically, the invention relates to the field of herbal compositions, especially decoctions for oral administration containing rhubarb and other herbal ingredients.
Body weight and body composition is determined by the competing balance of food intake and energy expenditure. Although both genetic and environmental factors can contribute to obesity, the most common cause of weight gain and an overweight body composition is excessively high caloric intake accompanied by a lack of physical activity. The resulting accumulation of surplus fat places overweight or obese individuals at increased risk of illness from hypertension, lipid disorders, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, certain cancers, and a wide variety of other diseases and undesired physiological conditions, as well as overall mortality. According to a study, the proportion of overweight individuals in the United States increased from 25% in 1980 to 33% in 1991. (Third National Health and Nutrition Examination Survey, 1991). In 1998 the National Institutes of Health reported that over 55 percent of the U.S. population are now considered overweight or obese. (Obesity Clinical Guidelines: NIH Statement Jun. 3, 1998, press release).
Obesity may become partially reversed or prevented by employing diet or nutrition and behavior modification programs or by using pharmaceutical intervention. Among the most widely administered drugs are: orlistat, which reduces the amount of dietary fat that is absorbed from the intestine; sibutramine, which suppresses appetite by inhibiting the re-uptake of norepinephrine and serotonin; fenfluramine and d-fenfluramine, which suppress appetite by both releasing serotonin and then inhibiting its re-uptake; and phentermine, which suppresses the appetite by stimulating the release of norepinephrine.
Most weight reduction drugs typically achieve only a 5-10% decrease in body weight. (National Task Force on the Prevention and Treatment of Obesity: Long-term pharmacotherapy in the Management of Obesity, JAMA 276:1907-15, 1996). In addition, most drugs have mild to serious side effects. For example, the once popular appetite suppressant drug xe2x80x9cFen-Phenxe2x80x9d (the combination of fenfluramine and phentermine), which gave a 15-20% reduction in body weight, was clinically determined to have significantly increased the risk of heart valve damage. (F. Brenot et al., Appetite Suppressant Drugs and the Risk of Primary Pulmonary Hypertension, N. Engl. J. Med., 335:609-16, 1996). Consequently, after a number of confirmed xe2x80x9cFen-Phenxe2x80x9dxe2x80x94related patient deaths, most of the drugs containing fenfluramine have been recalled and withdrawn. (Connolly H. M. et. al., N. Eng. J. Med. 337:581-88, 1997). In 1999 the FDA removed fenfluramine from the market. Other common side effects include dizziness, headaches, rapid pulse, palpitations, sleeplessness, hypertension, diarrhea, and intestinal cramping.
In addition to adverse side effects, current weight loss drugs may be habit forming, as exemplified by drugs containing amphetamines, and the initial weight reducing effect of many drugs wears off over time, requiring increased dosages to maintain weight reduction. The most serious problem, however, is that the lost weight is frequently regained after the drug is discontinued and the fairly limited utility of these drugs is more than offset by the side effects and other drawbacks inherent in their use.
The following table provides a synopsis of some of the characteristics of the most popular weight loss drugs and notes some of the impediments to wide-scale use:
Various natural herbal weight reduction formulas have been suggested as safer alternatives to both prescription and over-the-counter weight loss compounds. Generally, herbal weight loss formulas have fewer side effects when properly formulated and administered. Despite the fact that herbs are natural substances, however, some herbal formulas can still be abused. For example, improper administration of herbal weight loss formulas based primarily on ma huang (ephedra) and high caffeine-containing herbs, such as guanrana and kola nut, may result in diminished energy and a depleted body.
New compounds for treatment of humans are often tested in animal models to insure their safety and efficacy. A number of rat models have been used to study the effect of drugs on obesity. Diet-related obesity can be created in the Osbom-Mendel, Wistar and Sprague-Dawley rats by altering their diets to increase caloric consumption. This is usually accomplished by increasing the percentage of fat in a carefully controlled diet and measuring a series of physiologic parameters that indicate changes in energy metabolism, weight gain, weight loss, body composition, and other indicia of overall health and the balance between food intake and energy expenditure. These rats experience the increased weight and fat deposition characteristically seen in obese humans. Using these models, compounds that are candidates for agents to control body weight and composition are tested for safety and efficacy. Typically, drugs that prevent weight gain or cause weight loss in rat models are also effective in humans, albeit at a slightly lower level of efficacy. Given the serious problems associated with obesity, and the significant drawbacks associates with many weight loss compounds, a need exists for a safe and effective composition that reduces weight gain, causes weight loss, and improves body composition.
The present invention is comprised of compositions and methods for effecting weight reduction, specifically, herbal formulations and methods for their administration to reduce body weight prevent weight gain and lower blood lipid and sugar levels. At the physiological level, the compositions alter the balance of food intake and energy metabolism to favor weight reduction and the improvement of body composition by reduction of fat and overall lipid levels. The compositions are comprised of a combination of more than one herb, and specifically chemical extracts from herbs, that are formulated in a special combination such that the individual components are combined for their individual utilities in the weight loss context, as well as for their synergistic effect in the complete composition of the invention. Each herb is identified by its botanical characteristics, as well as by the chemical compounds contained within the plant that may be extracted by chemical manufacturing processes. Accordingly, chemical compounds and individual constituents of the herbs, individually and collectively, that mimic the effect of the herbs and herbal extracts may be substituted for the actual herbs obtained from nature without departing from the spirit and utility of the invention. In a preferred embodiment, the compositions of the invention include another rhubarb that is specially processed in a decoction and used in combination with other herbal compositions and extracts that enhance the physiological utility of rhubarb and its derivatives. In a preferred embodiment, the composition contains the functional chemical components of rhubarb in combination with other agents that allow the ingestion of rhubarb extracts without side effects.
In use, the compositions of the invention can be administered orally in a liquid or tablet form and may be combined with food as part of an obesity treatment regimen or as a dietary or fitness supplement. When provided to non-humans, the compositions of the invention may be administered separately or may be combined with ordinary feed or liquid nourishment to effect the alterations in body composition as described herein. Thus, the compositions of the invention include the herbal compositions described herein in oral dosage form, or in combination with any of the usual pharmaceutical or nutritional media employed in the art for oral liquid preparations, e.g., suspensions, elixirs, and solutions. Generally, media containing water, oils, alcohols, flavoring agents, preservatives, coloring agents and the like may also be used for flavor, texture, or shelf-life enhancement. Carriers such as starches, sugars, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like may be used to prepare oral solids (e.g., powders, capsules, pills, and tablets). Controlled release forms may also be used. Because of their ease in administration, tablets, pills, and capsules represent advantageous oral dosage unit forms, in which case solid pharmaceutical carriers are employed. If desired, tablets may be sugar coated or enteric coated by standard techniques. While the herbs and herb extracts of the invention are naturally derived from plants that are edible, the compositions of the invention can be administered as herbs or direct extracts of herbs, but one or more herbs can also be substituted with the chemical compounds or functional equivalents that are derived from such herbs. For example, one component of an embodiment of the invention is turmeric. The main functional ingredient of turmeric is known to be curcumin, an organic molecule whose structure and function are well known. Thus, consistent with the invention, the turmeric herb may be replaced in some applications with the organic molecule contained therein. Moreover, the compositions of the invention can be combined with ordinary foods to enhance the value of the weight control capabilities. For example, the compositions can be mixed with soft drinks, food supplements, candy, or high-energy bars, and virtually any other food that can be supplemented with a powder or liquid. Thus, the invention specifically includes food substances of specific types combined with the composition of the invention in specified forms and quantities.
A preferred embodiment of the herbal formulation is comprised of a combination of rhubarb root and stem (radix et rhizoma rhei), astragalus root (radix astragali), red sage root (radix salviae miltiorrhizae), turmeric (rhizoma curcumae longae), and dried ginger (rhizoma zingiberis officinalis). The herbal formulations are preferably administered orally in a dosage range that results in a decrease of body weight, normalization of the metabolic rate, and reduction of blood lipid and sugar level. In a preferred experimental application of the invention, rats administered with 5 grams per day of the herbal composition lost about 39% of their pretreated weight and 60% of their pretreated cholesterol level.